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Model Number 7209485 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/15/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that, during the procedure, the loop retriever in the "meniscus mender ii (disposable set)" was disassembled between the head and shaft when the package was opened.Although the surgery was not delayed, it is unknown how the procedure was completed.No patient injuries or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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Internal complaint reference (b)(4).H10, h3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection revealed that the suture loops had been broken off of their handles.One was bent upwards, indicating that the device had been removed from the packaging via pulling on the metal shaft.These devices are intended to be removed by applying pressure behind the package to pop the handle out of the plastic.A review of the device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.The complaint was confirmed and the root cause was associated with device design.Corrective actions have been initiated and are ongoing.
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Search Alerts/Recalls
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